Major purpose of the Job: -Formulation development of oral solid and liquid oral products for regulated, semi regulated and other international market. - Technology transfer, Process and Cost optimization, Support in commercial validation and Market launch - Lead, guide, mentor and manage a team of scientist and technical staff towards timely product delivery. Key Responsibilities: - Preparation of strategies for new product development as per the market needs. - Responsible for Pre-formulation and formulation activities as per QbD approach towards developing robust, bioequivalent and stable products. - Responsible for end to end integration of development activity at lab scale to regulatory filling and commercial launching. - Preparation of strategies and documentation for executing scale up and EB batches at plant location. - Troubleshooting and resolving manufacturing or quality-related issues following company quality policy. - Responsible to address regulatory deficiencies, striving for timely and early product approval. - Process validation activities and technology transfer of product from lab scale to commercial scale. - Alternate source development of API and Excipient towards cost improvement of existing products for regulated and other international market. - Ensure projects are developed and completed on time within stipulated budget, meeting all quality and regulatory expectations. - Actively participation in meetings with internal stakeholders and external clients and translate all technical or strategic input into actionable tasks with monitoring of project progress. - Contribute to the ideation, conceptualization and development of new, novel, innovative and patentable products. - Manage day-to-day activities of the team, assign tasks, mentor associates, and provide regular feedback. - Collaborating and building strong working relationships with cross function team to drive timely regulatory filing and successful market launch. - Driving continuous improvement in system and processes, leading to technical, solution and cost improvement enhancements. - Fostering and promoting a positive, transparent and collaborative team environment, - Act as a bridge between the team and upper management, providing regular updates and feedbacks. - To get need base training for Excellence and continuing education as and when required.
